BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    Dual Stage Venous Cannulae

    K Number: K253671 · Decision Jan 30, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    104
    Registration Numbers
    104
    Same Product Code
    400
    Applicant Total
    61
    Review Days
    70

    Basic Information

    Device Name
    Dual Stage Venous Cannulae
    K Number
    K253671
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4210
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sorin Group Italia S.R.L.
    Date Received
    November 21, 2025
    Decision Date
    January 30, 2026
    Product Code
    DWF
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

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